Tecfidera (dimethyl fumarate)
An approved treatment for Multiple Sclerosis.
The same compound appears under different names depending on the context. Here is how to identify Dimethyl fumarate wherever you encounter it, plus the key facts at a glance.
- Generic name
- Dimethyl fumarate
- Brand name
- Tecfidera
- Development code
- BG-12
- Drug class
- Oral immunomodulator
- Manufacturer
- Biogen
- How it's taken
- Taken as delayed-release capsules twice daily by mouth.
A twice-daily oral pill for adults with relapsing forms of MS (including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS) that activates the body's antioxidant defenses and reduces inflammation. It is not approved for children. One of the most widely prescribed oral MS therapies, reducing relapses by about 45%.
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Where Dimethyl fumarate fits
Widely used oral first-line therapy for relapsing MS. Generic availability has made it one of the most cost-effective oral disease-modifying options.
How Dimethyl fumarate works
Dimethyl fumarate activates a protein that protects nerve cells and reduces inflammatory molecules. It shifts your immune system from causing inflammation to preventing it, changing how immune cells behave rather than directly killing them.
Mechanism: Activates the Nrf2 antioxidant pathway while modulating proinflammatory signaling and dendritic cell differentiation
Side effects and safety
Common side effects are flushing (feeling hot and red), stomach pain, nausea, and diarrhea, especially when starting. Serious risks include severe allergic reactions (anaphylaxis and angioedema, which mean stopping the drug for good), liver damage, low lymphocyte counts, serious infections such as shingles (herpes zoster) and other opportunistic infections, and in rare cases a brain infection called PML. Serious stomach and bowel problems, including bleeding, ulcers, tears (perforation), and blockage, have been reported, some fatal and most within the first 6 months, so get medical help for new or worsening severe stomach symptoms. Regular blood tests are needed.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Dimethyl fumarate
Taken as delayed-release capsules twice daily by mouth. Start with 120 mg twice daily for 7 days, then switch to 240 mg twice daily. Swallow capsules whole. Food may reduce stomach upset.
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
Oral immunomodulator available in generic form with multiple manufacturers. Small molecule with well-established manufacturing and broad prescribing history.
Help paying for Tecfidera
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Biogen Copay Program may lower cost of brand-name Tecfidera to as little as $0 for eligible commercially insured patients; annual cap applies. Medicare, Medicaid, VA/DoD excluded.
For: private insurance · source - Insurance and case manager help
Biogen Support Coordinators explain coverage and costs, help with prior authorization, and check options for government-insured, uninsured or underinsured patients.
The official page does not say who qualifies. Ask the program. · source
Good to know: Program covers brand-name Tecfidera only; generic dimethyl fumarate is widely available and not covered. For uninsured or underinsured patients, Biogen says it will research other possible financial help, but no Biogen free-drug program is described.
- From a charity · TotalAssist (formerly PAN Foundation)Multiple Sclerosis fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $8,000 per year. Requires Medicare, Medicaid or TRICARE.
- From a charity · The Assistance FundMultiple Sclerosis fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
Clinical trial results
Two Phase 3 trials (DEFINE and CONFIRM) showed dimethyl fumarate reduced annual relapses by up to 53% and brain lesions by up to 90%. Approved by the FDA in March 2013.
Development history
Biogen developed dimethyl fumarate under the code name BG-12 and received FDA approval as Tecfidera in March 2013. Its oral formulation made MS treatment more convenient than injectable alternatives.
Explore Multiple Sclerosis trials
Other Multiple Sclerosis treatments
Common questions about Dimethyl fumarate
▸What is Dimethyl fumarate (Tecfidera)?
A twice-daily oral pill for adults with relapsing forms of MS (including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS) that activates the body's antioxidant defenses and reduces inflammation. It is not approved for children. One of the most widely prescribed oral MS therapies, reducing relapses by about 45%.
▸How does Dimethyl fumarate work?
Dimethyl fumarate activates a protein that protects nerve cells and reduces inflammatory molecules. It shifts your immune system from causing inflammation to preventing it, changing how immune cells behave rather than directly killing them.
▸What are the side effects of Dimethyl fumarate?
Common side effects are flushing (feeling hot and red), stomach pain, nausea, and diarrhea, especially when starting. Serious risks include severe allergic reactions (anaphylaxis and angioedema, which mean stopping the drug for good), liver damage, low lymphocyte counts, serious infections such as shingles (herpes zoster) and other opportunistic infections, and in rare cases a brain infection called PML. Serious stomach and bowel problems, including bleeding, ulcers, tears (perforation), and blockage, have been reported, some fatal and most within the first 6 months, so get medical help for new or worsening severe stomach symptoms. Regular blood tests are needed.
▸How is Dimethyl fumarate taken?
Taken as delayed-release capsules twice daily by mouth. Start with 120 mg twice daily for 7 days, then switch to 240 mg twice daily. Swallow capsules whole. Food may reduce stomach upset.
▸Is Dimethyl fumarate FDA approved?
Yes, Dimethyl fumarate (Tecfidera) is FDA approved (2013) for the treatment of Multiple Sclerosis.
▸Why does dimethyl fumarate cause flushing?
Flushing (feeling hot, red, and itchy) is the most common side effect, affecting about 40% of patients. It occurs because dimethyl fumarate activates prostaglandin pathways in the skin. The flushing typically starts within the first month of treatment and tends to decrease over 2-3 months as the body adapts. Taking the medication with food, especially food with some fat, can reduce flushing. Some doctors recommend taking a non-enteric-coated aspirin (325 mg) 30 minutes before the dose to minimize flushing.
▸Is generic dimethyl fumarate available?
Yes. Generic dimethyl fumarate became available after Tecfidera's patent protections ended. Multiple manufacturers produce generic versions, significantly reducing costs. An alternative branded formulation, diroximel fumarate (Vumerity), converts to the same active metabolite (monomethyl fumarate) but may cause fewer GI side effects. Generic dimethyl fumarate remains the most cost-effective option in this drug class.
▸How does dimethyl fumarate compare to other oral MS drugs?
Dimethyl fumarate reduces relapses by 44-53%, placing it in the moderate-to-high efficacy range among oral MS drugs. Its main side effects (flushing, GI symptoms) are different from S1P modulators (cardiac effects) or teriflunomide (hair thinning, teratogenicity). Unlike teriflunomide, dimethyl fumarate has no specific pregnancy washout requirement. The label says pregnancy registry and other data have not shown an increased risk of birth defects or miscarriage, but anyone pregnant or planning pregnancy should talk with their neurologist. The availability of a generic makes it one of the most cost-effective oral options.
▸What blood tests are needed while taking dimethyl fumarate?
A complete blood count (CBC) with lymphocyte count should be checked before starting, at 6 months, and then every 6 to 12 months. Dimethyl fumarate can lower lymphocyte counts, and sustained lymphopenia (low lymphocyte count) increases the risk of opportunistic infections including PML. If lymphocyte counts fall below 500 cells per microliter for more than 6 months, your neurologist may consider discontinuing the drug. Liver function tests may also be monitored.
▸What is the difference between dimethyl fumarate and diroximel fumarate?
Both convert to the same active metabolite (monomethyl fumarate) in the body and have equivalent efficacy. Diroximel fumarate (Vumerity) was designed to cause fewer gastrointestinal side effects than dimethyl fumarate. In clinical trials, patients switching from dimethyl fumarate to diroximel fumarate reported fewer GI symptoms. However, diroximel fumarate is only available as a brand-name product and is more expensive than generic dimethyl fumarate.